Adverse Event Data Collection From the EUHASS Registry on Turoctocog Alfa Pegol

This non-interventional study concerns a safety data collection based on adverse event data from a third-party registry (European Haemophilia Safety Surveillance System, EUHASS) that includes information about adverse events from patients with haemophilia A treated with turoctocog alfa pegol. There is no extra burden to the patients by participating in this registry-based data collection.

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Key information

Conditions

Haemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Søborg, 2860, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participation in the European Haemophilia Safety Surveillance System (EUHASS).

Exclusion criteria

Treatment and study plan

Turoctocog alfa pegol

Drug

Patients will be treated with commercially available turoctocog alfa pegol according to routine clinical practice at the discretion of the treating physician. A decision to initiate treatment with commercially available turoctocog alfa pegol has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in the registry in scope.

Primary outcomes

Adverse events (AEs) reported to the registry with suspected relation to turoctocog alfa pegol, Adverse Drug Reactions (ADRs), in patients with haemophilia A for renal, hepatic and neurological events.

Time frame: From start to end of data collection (December 2019 to January 2025)

Count

Secondary outcomes

Other AEs reported to the registry during the study period with suspected relation to turoctocog alfa pegol in patients with haemophilia A

Time frame: From start to end of data collection (December 2019 to January 2025)

Count. Includes ADRs of special interest (de novo FVIII inhibitors equal to or above 0.6 Bethesda Units (BU)); anaphylaxis and other allergic reactions; thromboembolic events).

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start: 2020
Primary completion: 2026
Study completion: 2026
First posted: Dec 23, 2020
Registry last updated: Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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